Record patent expirations roil Rx market

For branded drug makers, the pharmaceutical patent cliff has never loomed higher or steeper. The exposure of so many of the world’s biggest-selling medicines to generic competition for the first time is redefining the pricing model for many of the most widely prescribed classes of pharmaceuticals — reducing costs for health plans, payers and patients; scrambling drug makers’ balance sheets; and potentially boosting both drug utilization and adherence rates as reduced out-of-pocket costs induce more patients to fill their prescriptions.

According to IMS Health, drugs generating more than $102 billion in combined annual sales will reach the end of their patent life over the next five years. In 2012, that march over the patent cliff is led by the anti-clotting blockbuster Plavix, from Bristol-Myers Squibb and Sanofi. Plavix, the world’s top-selling pharma product following the opening to generic competition of Pfizer’s Lipitor last fall, generated $6.8 billion in 2011 revenues, according to IMS Health. But the drug will face rampant generic competition following expiration of the 180-day marketing exclusivity period for the drug’s first-to-file me-too competitors — Mylan Pharmaceuticals and Dr. Reddy’s Laboratories — in mid-November.

The impact on the market for heart medicines already has been dramatic. Bristol-Myers reported that sales of Plavix plunged 60% in its fiscal second quarter following loss of patent protection, to $741 million. The drug’s exposure to generic competition will only increase with the end of the 180-day exclusivity period for Mylan and Dr. Reddy’s, but Bristol already is shifting its focus in the anti-clotting category to gaining Food and Drug Administration approval for promising new treatments like Eliquis, which the company is co-developing with Pfizer.

Other drugs losing patent protection this year include AstraZeneca’s antipsychotic mega-seller Seroquel, No. 6 on IMS’ list of top-selling U.S. pharmaceuticals, with $4.6 billion in 2011 sales; and Merck’s biggest-selling drug, the $3.4 billion asthma and allergy medication Singulair. Merck is reportedly predicting sales of Singulair will plummet 90% as a swarm of low-priced generic copies grab market share.

This year’s list of expiring patents goes on. Also reaching the end of their market exclusivity are the blockbusters Lexapro, Forest Laboratories’ antidepressant that saw its first generic competition in March; Actos, the oral Type 2 diabetes medicine from Takeda Pharmaceuticals that generated billions in sales before its use was linked to increased risk of bladder cancer; and Viagra, Pfizer’s breakthrough erectile dysfunction treatment.

Next year will see the scheduled end of patent life for Purdue Pharma’s $3 billion blockbuster OxyContin. In 2014, AstraZeneca’s $6 billion heartburn treatment Nexium for gastroesophageal reflux disease joins the post-patent market scramble, along with Eli Lilly’s $3.7 billion nonsteroidal anti-inflammatory pain reliever Cymbalta and Pfizer’s NSAID Celebrex for treatment of arthritis. Add the MS drug Copaxone from Teva to the patent cliff in 2015, followed in 2016 by the blockbuster statin Crestor from IPR Pharmaceuticals and AstraZeneca.

The inevitable result of all the expiries will likely be a race-to-the-revenue-bottom scramble for control of some of the most lucrative and medically significant therapeutic classes of pharmaceuticals dispensed by U.S. pharmacies. In a report on the global outlook for pharmaceuticals, IMS predicted “an accelerated shift to spending in generics … due to patent expiries, with some additional increases due to expanded generic use for off-patent molecules.”

The impact on pharmacy retailers’ topline sales — and to consumers’ and health plan payers’ pocketbooks — can be dramatic. According to IMS, “over 80% of a brand’s prescription volume is replaced by generics within six months of patent loss.”

Among branded drug houses, the loss of protection is likely to spawn waves of discounting and couponing on post-patent drugs, much like what Pfizer did in the wake of Lipitor’s loss of patent life last November. Indeed, aggressive discounting and other moves by Pfizer to preserve some of Lipitor’s market share vis-à-vis health plan payers and patients initially triggered a wave of discounting, direct-to-consumer advertising and other moves by manufacturers within the statin drug class; the same result could follow in other therapeutic classes during the initial six-month exclusivity period for first-to-file generic competitors.

Those rear-guard actions, however, may only forestall the inevitable dominance of generics within statins and other drug classes as their biggest standard-bearers face me-too competition and pharmacy benefit managers aim to cut drug costs through restricted formularies. Noted Thomas Reinke of Managed Care Magazine, “Experts predict that the preferred formulary for statins could [eventually] comprise all generic agents, with brand medications available on a nonpreferred or step-through basis.”

What could change that dynamic, of course, would be the introduction of new, innovative chemical entities — developed either through traditional research and development or via bioengineering — into the market for statins and other therapeutic classes impacted by patent expirations.

According to IMS, the pipeline for new molecular entities is indeed looking somewhat more robust after a long dry spell in new drug introductions with blockbuster potential. But at least half those new products will be specialty and biologically derived targeted therapies for cancer, autoimmune diseases, Alzheimer’s and other conditions, predicted Michael Kleinrock, head of research for IMS. “We’re not talking about a return to the late ’90s or the early 2000s, when there were 40 or more [new molecular entities] some years, and they’re not all mega-blockbuster products,” he told Medical Marketing & Media. “There will be more specialty; there will be new mechanisms of action for therapeutic areas and orphan drugs.”

The new-drug pipeline notwithstanding, the generic wave is all but unstoppable. The forces driving it, most notably the cost-cutting imperatives of government and for-profit health plans and payers, are woven into the fabric of the pharmaceutical and healthcare marketplace.

“The opportunity for lowering costs by promoting generics over brands has never been greater, given the unprecedented number of drugs set to lose patent protection over the next few years,” noted the 2012 Towers Watson/National Business Group on Health Employer Survey on Purchasing Value in Health Care.

“We all need to prepare to operate in a world where you’ve got 80% to 85% generic penetration on large molecules, and … individualized specialty drugs,” said Jeff Berkowitz, SVP pharmaceutical development and market access for Walgreens.

Indeed, experts like Doug Long, VP industry relations for IMS, are predicting that the era of traditionally derived blockbusters is nearing its end for the drug industry. New, broad-spectrum treatments for widespread conditions like hyperlipidemia, Long said, are likely to achieve more modest revenue results as payers and PBMs shift to cheaper generics.

Instead, the drug industry is shifting much of its focus to more specialized and more expensive specialty medicines that target smaller groups of patients with specific conditions in disease states like cancer and autoimmune disorders, according to IMS.

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